MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE PRECISION IE 4K C-MOUNT ARTHROSCOPE, AUTOCLAVABLE, 4MM X 70°, 140MM, SPEED-LOCK

Model Number	0502-404-070
Medical Device Problem Code	Optical Problem (3001)
Health Effect - Clinical Codes	Unspecified Tissue Injury (4559); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/15/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional information will be provided once the investigation has been completed.The device manufacturer date is not known at this time.However, should it become available it will be provided in future reports.
Event or Problem Description
It was reported that the procedure was converted to open.
Additional Manufacturer Narrative
The product was not returned for investigation and the reported failure mode was not confirmed.Alleged failure: fogging and condensation: probable root cause: laser welding seal failure, distal/proximal window solder failure, damage to optical train, damage to needle, damage to distal or proximal windows, moisture intrusion, end of life wear-out, environmental disturbance: endoscope colder than dew point.Environmental disturbance: fluid entrapment between the coupler and eyepiece.Junction (eyepiece only).Use error.The device manufacture date is not known.The failure mode will be monitored for future reoccurrence.H3 other text: 81.
Event or Problem Description
It was reported that the procedure was converted to open.

• Brand Name: PRECISION IE 4K C-MOUNT ARTHROSCOPE, AUTOCLAVABLE, 4MM X 70°, 140MM, SPEED-LOCK
• Common Device Name: ARTHROSCOPE
• Manufacturer (Section D): STRYKER ENDOSCOPY-SAN JOSE; 5900 optical court; san jose CA 95138
• Manufacturer (Section G): STRYKER ENDOSCOPY-SAN JOSE; 5900 optical court; san jose CA 95138
• Manufacturer Contact: chester rebugio ; 5900 optical court; san jose, CA 95138 ; 4087542000
• MDR Report Key: 12800902
• Report Number: 0002936485-2021-00624
• Device Sequence Number: 17332673
• Product Code: HRX
• UDI-Device Identifier: 07613327416473
• UDI-Public: 07613327416473
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K183470
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 0502-404-070
• Device Catalogue Number: 0502404070
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/15/2021
• Supplement Date Received by Manufacturer: 10/15/2021
• Initial Report FDA Received Date: 11/11/2021
• Supplement Report FDA Received Date: 01/12/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown